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Regulatory Specialist : FDA & Global Compliance - Full Time Hybrid

4 hours, 3 minutes ago
United States
Full-time
Senior
Compliance Manager
Quality Assurance and Testing
Apply Now
Retinai

Retinai

RetinAI accelerates ophthalmology workflows with AI-driven insights, optimizing patient outcomes and research processes.

Internet Software & Services
11-50
Founded 2017
$3M raised
View All Jobs 6

Description

  • Prepare and manage FDA regulatory submissions, including 510(k), De Novo, Pre-Submission, and Breakthrough Designation filings.
  • Ensure regulatory documentation is complete, accurate, and compliant with applicable requirements.
  • Coordinate cross-functional inputs for submissions, including clinical, risk, usability, and technical documentation.
  • Support U.S. compliance and reimbursement activities, including CPT code strategy and payer engagement.
  • Support SOC2 certification efforts and data privacy/security compliance activities.
  • Maintain and improve QMS processes related to regulatory compliance and product quality.
  • Review promotional and training materials for regulatory compliance.
  • Support design control, risk management, documentation updates, and change management activities.
  • Support internal, external, and notified body audits, as well as supplier and distributor compliance processes.
  • Collaborate with clinical, R&D, product, and legal teams on regulatory requirements and product development.

Requirements

  • Bachelor’s or Master’s degree in Life Sciences, Engineering, Regulatory Affairs, or a related field.
  • 7+ years of experience in regulatory affairs with a strong FDA focus.
  • Experience with FDA submissions, including 510(k), De Novo, and Pre-Submission pathways.
  • Experience with Software as a Medical Device (SaMD).
  • Knowledge of ISO 13485 and ISO 14971 requirements.
  • Knowledge of MDR and the EU regulatory framework.
  • Experience with clinical studies, including retrospective and prospective studies.
  • Understanding of the U.S. reimbursement landscape is a plus.
  • Experience with SOC2 or MDSAP is a plus.
  • Strong analytical and problem-solving abilities, with high attention to detail and the ability to manage multiple projects simultaneously.

Benefits

  • Competitive salary.
  • Supportive work environment that fosters work-life balance.
  • Opportunities for professional growth and development in an international setting.
  • Collaborative and inclusive company culture.
  • Occasional travel to the company headquarters in Switzerland.

Interested in this position?

Apply directly on the company website

Apply Now

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